Flush Syringe With Flip Cap

ABSTRACT

Flush syringe assemblies are described herein. Such flush syringe assembly may include a barrel including a side wall defining a chamber, a collar mounted on a distal wall of the barrel and surrounding an elongate tip. A cap may be attached to the collar via a hinge. The flush syringe assembly may also include a cap attached to the collar via a hinge. A ring may be disposed around the collar with a locking element that engages with a corresponding mating locking projection on the cap. The cap may include a slanted surface. The slanted surface of the cap may include one or more ribs made of an elastomeric material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/253,683, filed on Jan. 22, 2019 which claims priority under 35 U.S.C.§ 119(e) to U.S. Provisional Application No. 62/622,517, filed Jan. 26,2018, the disclosures of which are incorporated herein by reference intheir entirety.

TECHNICAL FIELD

The present disclosure generally relates to syringe assemblies, andparticularly to syringe assemblies comprising a physical barrier toprevent contact of the syringe tip with the surrounding non-sterileenvironment. Embodiments of the present disclosure ensure adherence toaseptic techniques for use in flush procedures for vascular accessdevices (VAD's). Embodiments of the present disclosure are also directedto technology to reduce the risk for bloodstream infections (CRBSI) andintravenous (IV) line patency maintenance including capping technology,particularly for syringe assemblies to allow for one-handed removal of asyringe cap for use in flush procedures.

BACKGROUND

Vascular access devices (VADs) are commonly used therapeutic devices,which include peripheral catheters and central venous catheters. If notproperly maintained or if exposed to a non-sterile environment, the VADscan become contaminated, sealed with blood clots or spread infection. Toensure VADs are used properly and do not become sealed or infected,protocols to ensure sterile practice have been developed. Theseprotocols include sterilizing the VAD and flushing the catheter with aflush solution. Catheters are flushed using syringe assemblies filledwith various fluids. In some cases, different fluids are injectedsequentially in accordance with the protocol. For example, a salinesolution followed by an anticoagulant such as heparin. The size of thesyringe used to flush intravenous (I.V.) lines varies by various factorsincluding the size and length of the catheter. Typically syringes of 1ml, 3 ml, 5 ml and 10 ml volume are used. VAD protocols usuallyrecommend flush procedures be performed after catheter placement, beforefluid infusion, and before and after drug administration, bloodsampling, transfusions and parenteral nutrition. The goal of these flushprocedures is to confirm catheter patency, avoid drug incompatibilities,ensure the complete drug dose administration, prevent thrombus formationand minimize the risk of blood stream infections.

Currently existing pre-filled syringes have syringe tip caps thatrequire two hands for holding the syringe and cap removal. Conventionalflush syringes have a barrel with a luer tip at one end which is exposedto the non-sterile environment once the syringe tip is removed frompackaging thus providing an opportunity for undesired contamination.Consequently, there is a need for a syringe, particularly a flushsyringe, providing a physical barrier around the syringe tip whichpromotes aseptic practice by reducing or eliminating “touch”contamination of the syringe, particularly the tip of a syringe, withthe surrounding non-sterile environment. There is also a need for asyringe, particularly a flush syringe, which allows the clinician toopen a protective cap with one hand, without the hand being in closeproximity of the syringe tip. In addition to enhanced safety, such aone-handed operation would greatly improve workflow and efficiency.

SUMMARY

One aspect of the present disclosure pertains to a flush syringeassembly including aa barrel having a side wall having an inside surfacedefining a chamber for retaining a fluid, an open proximal end, a distalend including a distal wall with an elongate tip extending distallytherefrom having a passageway therethrough in fluid communication withsaid chamber. A collar may be mounted on the distal wall of the barreland surrounds the elongate tip. The collar includes at least one sidewall having an inside surface defining a compartment, an open distalend, a proximal end adjacent the distal wall of the barrel. A cap may beattached to the collar via a hinge. An elongated plunger rod disposedwithin the barrel, the plunger rod including a distal end and a proximalend, the distal end including a stopper slidably positioned influid-tight engagement with the inside surface of the barrel for drawingfluid into and driving fluid out of the chamber by movement of thestopper relative to the barrel. The elongated plunger rod extendingoutwardly from the open proximal end of the barrel and the stopper has adistal surface.

In one or more embodiments, the compartment of the collar surrounds theelongated tip.

In one or more embodiments, the hinge is a living hinge.

In one or more alternate embodiments, the hinge is a butterfly shapewith a central hinge section and two lateral wings.

In one or more alternate embodiments, the hinge is spring loaded.

In one or more alternate embodiments, the hinge opens between a fullyclosed position to a fully open position of at least 120 degrees.

In one or more alternate embodiments, the cap includes an outwardlyextending protrusion that interacts with the elongate tip.

In one or more embodiments, the protrusion may be button-shaped,pin-shaped, or umbrella-shaped.

In one or more embodiments, a gasket may be disposed between the collarand the cap.

In one or more embodiments, the locking element is the form of an arm.

In one or more embodiments, the cap includes a slanted surface. In oneor more embodiments, the slanted surface may include one or more ribs.The one or more ribs may be made of an elastomeric material.

Another aspect of the present disclosure pertains to a flush syringeassembly including a barrel including a side wall having an insidesurface defining a chamber for retaining a fluid, an open proximal end,a distal end including a distal wall with an elongate tip extendingdistally therefrom having a passageway therethrough in fluidcommunication with said chamber. A collar may be mounted on the distalwall of the barrel and surrounding the elongate tip, the collarincluding at least one side wall having an inside surface defining acompartment, an open distal end, a proximal end adjacent the distal wallof the barrel. In one or more embodiments, a cap may be attached to thecollar via a hinge. In one or more embodiments, a ring is disposedaround the collar with a locking element that engages with acorresponding mating locking projection on the cap. In one or moreembodiments, an elongated plunger rod disposed within the barrel, theplunger rod comprising a distal end and a proximal end, the distal endincluding a stopper slidably positioned in fluid-tight engagement withthe inside surface of the barrel for drawing fluid into and drivingfluid out of the chamber by movement of the stopper relative to thebarrel, the elongated plunger rod extending outwardly from the openproximal end of the barrel.

In one or more embodiments, the ring may be turned to disengage thelocking element from mating locking projection on the cap. In one ormore embodiments, the ring includes one or more thumb supports. In oneor more embodiments, the locking element is the form of an arm.

In one or more embodiments, the cap includes a slanted surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a flush syringe with a flip capand locking element in an open position in accordance with one or moreembodiments of the present disclosure;

FIG. 2 illustrates a perspective view of a flush syringe with a flip capand locking element in an open position in accordance with one or moreembodiments of the present disclosure;

FIG. 3 illustrates a perspective view of a ring with locking element andturn tab in accordance with one or more embodiments of the presentdisclosure;

FIG. 4 illustrates a side view of a ring of FIG. 3 in accordance withone or more embodiments of the present disclosure;

FIG. 5 illustrates a top a ring of FIG. 3 in accordance with one or moreembodiments of the present disclosure;

FIG. 6 illustrates a partial perspective view of a flush syringe with ahinge connecting the collar and cap in accordance with one or moreembodiments of the present disclosure;

FIG. 7 illustrates a cross-sectional perspective view of a flush syringewith a collar and a cap in accordance with one or more embodiments ofthe present disclosure.

FIG. 8 illustrates a partial perspective view of a collar and a cap withsealing protrusion in the shape of a button and locking element inaccordance with one or more embodiments of the present disclosure.

FIG. 9 illustrates a side view of a syringe assembly with a collar, aring and a cap in an open position in accordance with one or moreembodiments of the present disclosure.

FIG. 10 illustrates a top view of a syringe assembly with a collar, aring and a cap in an open position in accordance with one or moreembodiments of the present disclosure.

FIG. 11 illustrates a partial perspective view of a flush syringe with acollar, hinge and a cap in accordance with one or more embodiments ofthe present disclosure.

FIG. 12 illustrates a perspective view of a flush syringe with a collarand a cap in an open position without a ring in accordance with one ormore embodiments of the present disclosure.

FIG. 13 illustrates a perspective view of a flush syringe with a collarand a cap in an open position with a ring in accordance with one or moreembodiments of the present disclosure.

FIG. 14 illustrates a top view of a flush syringe with a collar, a ringand a cap in a closed position accordance with one or more embodimentsof the present disclosure.

FIG. 15 illustrates a back view of a flush syringe with a collar, a ringand a cap in a closed position accordance with one or more embodimentsof the present disclosure.

FIG. 16 illustrates a perspective view of a flush syringe with a collar,a ring and a cap in a closed position accordance with one or moreembodiments of the present disclosure.

FIG. 17A illustrates a top view of a cap with a butterfly hinge inaccordance with one or more embodiments of the present disclosure.

FIG. 17B illustrates an exploded side view of a syringe assembly with abutterfly hinge in accordance with one or more embodiments of thepresent disclosure.

FIG. 17C illustrates a perspective view of an inside of the cap with aprotrusion and butterfly hinge in accordance with one or moreembodiments of the present disclosure.

FIG. 17D illustrates a rear view of a syringe assembly with a butterflyhinge in accordance with one or more embodiments of the presentdisclosure.

FIG. 18A illustrates a view of a cap of the syringe assembly with aprotrusion in the shape of an umbrella pin blocking the elongated tip inaccordance with one or more embodiments of the present disclosure.

FIG. 18B illustrates a partial view of a protrusion shown in FIG. 18A inthe shape of an umbrella pin blocking the elongated tip in accordancewith one or more embodiments of the present disclosure.

FIG. 19A illustrates a side view of a flush syringe with a spring loadedhinge in accordance with one or more embodiments of the presentdisclosure.

FIG. 19B illustrates a perspective view of a spring loaded hinge asshown in FIG. 19A in accordance with one or more embodiments of thepresent disclosure.

FIG. 20A illustrates a front view of a cap showing a groove featureinside the cap that provides a seal when closed and engaged with theseal ring on the outer surface of the barrel collar in accordance withone or more embodiments of the present disclosure.

FIG. 20B illustrates a side view of a cap showing a groove featureinside the cap that provides a seal when closed and engaged with theseal ring on the outer surface of the barrel collar in accordance withone or more embodiments of the present disclosure.

FIG. 21 illustrates a perspective view of a flush syringe with a collarand a cap in a closed position accordance with one or more embodimentsof the present disclosure.

FIG. 22 illustrates a perspective view of a flush syringe with a collarand a cap in an open position accordance with one or more embodiments ofthe present disclosure.

FIG. 23 illustrates a perspective view of a flush syringe with a collarand a cap in an open position attached to a vascular access device inaccordance with one or more embodiments of the present disclosure.

FIG. 24 illustrates a perspective view of a flush syringe with a collarand a cap in use accordance with one or more embodiments of the presentdisclosure.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the presentdisclosure, it is to be understood that the disclosure is not limited tothe details of construction or process steps set forth in the followingdescription. The disclosure is capable of other embodiments and of beingpracticed or being carried out in various ways.

With respect to terms used in this disclosure, the following definitionsare provided.

Reference to “flush syringe assembly” includes syringes that areindicated for use in the flushing of VADs. The practice of flushingensures and maintains catheter patency and helps prevent the mixing ofincompatible pharmaceuticals.

As used herein, the use of “a,” “an,” and “the” includes the singularand plural.

As used herein, the term “catheter related bloodstream infection” or“CRBSI” refers to any infection resulting from the presence of acatheter or IV line.

As used herein, the term “Luer connector” refers to a connection collarthat is the standard way of attaching syringes, catheters, hubbedneedles, IV tubes, etc. to each other. The Luer connector consists ofmale and female interlocking tubes, slightly tapered to hold togetherbetter with even just a simple pressure/twist fit. Luer connectors canoptionally include an additional outer rim of threading, allowing themto be more secure. The Luer connector male end is generally associatedwith a flush syringe and can interlock and connect to the female endlocated on the VAD. A Luer connector comprises a distal end, a proximalend, an irregularly shaped outer wall, a profiled center passageway forfluid communication from the chamber of the barrel of a syringe to thehub of a VAD. A Luer connector also has a distal end channel thatreleasably attaches the Luer connector to the hub of a VAD, and aproximal end channel that releasably attaches the Luer connector to thebarrel of a syringe.

Clinicians need to handle multiple components while accessing anintravenous (IV) line or catheter: open and disinfect the hub, open thesyringe, hold the line in place, etc. while ensuring that none of thedevices touch any surfaces as this would lead to contamination and bloodstream infections which can have deadly outcomes. Thus accessing anintravenous (IV) line or catheter is not straightforward and requires acertain level of dexterity to carry out the procedure while preventingthe syringe tip from coming into contact with the surroundingenvironment. If the syringe tip touches any non-sterile surfaces,“touch” contamination can occur which can cause microbial growth in theIV line and consequently lead to incidents ofcatheter-associated-bloodstream infection (“CRBSI”) and centralline-associated bloodstream infection (“CLABSI”) which are very costlyand lethal.

Embodiments of the present disclosure relate to a flush syringe having acollar and a hinged cap surrounding the elongate tip of the syringe. Thecollar provides a physical barrier around the syringe tip. Because ofits shape, the collar of the present disclosure can help facilitate thealignment of the flush syringe with the catheter hub and/or needle-freeconnector and thus reduce the chances of “touch” contamination.Embodiments of the present disclosure protect the syringe tip whilecurrently available syringes leave the syringe tip fully exposed once aprotective tip cap is removed, and therefore leaving the syringe tipprone to touch contamination. Embodiments of the present disclosurehaving an incorporated elevated collar surrounding the syringe tipenable ease of alignment of luer tips in devices such as needlelessconnectors and prefilled syringes, which can be very small, while alsoallowing for prevention of touch contamination. Absent the embodimentsof the present disclosure, alignment of luer tips require carefulattention and visual precision for being able to align the two partsperfectly such that no contamination occurs.

Referring to FIGS. 1-13, a syringe assembly 10 according to the presentdisclosure generally comprises a barrel 20, including a side wall 21having an inside surface defining a chamber 22 for retaining a fluid. Inone or more embodiments, the fluid is a flush fluid. The barrel 20further includes an open proximal end and a distal end having a distalwall with an elongated tip 23 extending distally therefrom and having apassageway 24 therethrough in fluid communication with the chamber, thedistal wall adapted for connection to a collar 30.

As shown in FIG. 2, collar 30 mounted on the distal end of the barrel20, the collar 30 including at least one side wall 31 having an insidesurface defining a compartment surrounding the elongated tip 23, a opendistal end 32, and a proximal end 33 adjacent the distal wall 25 of thebarrel. Elongated tip 23 adapted for connection to a hub of a vascularaccess device. As shown in FIG. 2, the inner surface of cap 40 has aprotrusion in the form of a button to block off a corresponding luer tipto prevent fluid leakage inside the cap area when closed,

In one or more embodiments, the collar 30 is an elevated collar aroundthe elongated tip 23. In one or more embodiments, the collar 30 is anextension of the barrel 20. Collar 30 aids in aligning the elongated tip23 to other luer devices, such as needleless connectors, and protectsthe elongated tip from touch contamination.

In one or more embodiments, as shown in FIGS. 3-5 and 13, the collar 30has a ring 60 around the collar 30 with a locking element 70 thatengages with its corresponding mating locking projection 71 on the cap40. The collar is turned to disengage the locking element 70 fromcorresponding mating locking projection 71 on the cap 40 to prepare thecap to be flipped open. In one or more embodiments, there are two thumbsupports 80 for turning the collar—one for left handed clinicians andone for right handed clinicians.

In one or more embodiments, the structure for automatically locking thecap 40 in a tip protecting position includes, at least one lockingelement 70 projecting from the exterior surface of the ring. In one ormore embodiments, locking element 70 may be in the form of an arm. Thearm includes a free end positioned so that when the cap 40 is pivoted tothe closed position, the free end of the arm engages a correspondingmating locking projection 71 on the exterior surface of the collar. Asshown in FIG. 2, locking element 70 may include a thumb turn handle 80to assist in turning the locking element to disengage the free end ofthe arm of locking element 70 from the corresponding mating lockingprojection 71 on the exterior surface of the collar

In one or more embodiments, as seen in FIG. 8, a slanted surface 90 isdisposed with one or more ribs 92 on the top surface of the cap 40 thatimproves grip. The inside surface of the cap 40 has an outwardlyextending protrusion 100 that blocks off the luer tip and preventsleakage when cap is closed. In one or more embodiments, protrusion 100may be in the shape of a pin or button, as seen in FIGS. 6-8.

In one or more embodiments, a cap 40 is attached to the collar 30 via ahinge 50. FIG. 6 illustrates a partial perspective view of a flushsyringe with a hinge 50 connecting the collar 30 and cap 40 inaccordance with one or more embodiments of the present disclosure. Inone or more embodiments, the hinge is a living hinge. In one or moreembodiments, cap 40 is a flip open cap. In one or more embodiments, cap40 includes a side wall defining a longitudinal opening and a top wallbetween the side walls defining a recess having an interior surface. Thecap is capable of pivoting from an open position wherein the elongatedtip 23 is exposed to a closed protecting position wherein the distal endof the elongated tip 23 is within the longitudinal opening of the cap.In one or more embodiments, the collar 30 and the cap 40 can be moldedtogether and then assembled with the barrel 20. In an alternateembodiment, the collar 30 and the syringe barrel 20 are molded togetherand the cap 40 gets attached to the assembly.

The outwardly extending protrusion 100 prevents leakage after thesyringe is filled and the cap 40 is closed until the cap 40 is openedprior to use. In one or more embodiments, the outwardly extendingprotrusion or pin may be orientated, configured and/or shaped to allowthe protrusion to enter the opening at the distal end of the elongatedtip, as seen in FIGS. 11-13.

As shown in FIG. 14, in one or more embodiments, thumb turn handle 80may comprise two or more two thumb supports (81, 82) for turning thecollar. In the exemplary embodiment shown in FIG. 14, thumb support 81is configured for a one for right handed clinicians and thumb support 82is configured for a left-handed clinicians.

The hinge 50 functions such that once the hinge 50 is opened, it remainsin place. In one or more embodiments, as shown in FIGS. 17A through 17D,the hinge 50 has a butterfly shape with a central section that serves asa hinge and the two wings on the sides to make it snap into place. Inone or more embodiments, the side profile of the central section is atriangular.

The inside surface of the cap 40 has an outwardly extending protrusion100 that blocks off the luer tip and prevents leakage when cap isclosed. In one or more alternate embodiments, as seen in FIG. 18 theoutwardly extending protrusion 100 may be shaped to resemble a smallumbrella, whereby the protrusion 100 forms an arc on the outside of thetop part of the distal end of the elongated tip. As shown in FIG. 18,the central part of the outwardly extending protrusion 100 is flatcontacting the inner part of a top surface of a corresponding syringetip and the outer edges are flared or curved downward to enclose the topsurface of a corresponding syringe tip which may have a steppedcurvature. As shown in FIGS. 18A and 18B, one or more embodiments of cap40 may include a protrusion 100 in the shape of an umbrella pin blockingthe elongated tip.

As shown in FIGS. 19A and 19B, in one or more embodiments, hinge 50 canalso be spring loaded, where the pre-tension of a spring 55 is adjustedsuch that once the cap 40 is popped open, the hinge 50 opens to therequired degree. In one more embodiments, the hinge in combination withthe spring element forms a hinge assembly. In one or more embodiments,the spring element may include a first segment and a second segmentaligned or compressed with respect to one and other in an initial closedcap condition. However, first and second segments of spring element canbe resiliently deflected by the resiliency inherent in spring element tourge the cap to an open position. The self-propelling attributes of thehinge in combination with the spring element are desirable to facilitateone-hand operation of the needle. The accumulated energy of the springperforms work for the user by urging the cap toward the open position toexpose the elongated tip. Spring element 55 will, preferably, be stablewith, preferably, little or no stored energy while in the open position.Hinge 50 which is operated or loaded with spring 55 allows for a capthat may be open to an angle greater than 120°.

In one or more embodiments, the hinge 50 opens between a fully closedposition to a fully open position to the required degree of at least 120degrees.

Other embodiment can additionally include a gasket feature between thecollar and the flip open cap to create a tight seal for maintainingsterility, as shown in FIG. 20. In one or more embodiments, theelongated tip may be a luer tip.

Other embodiment can additionally include a gasket feature between thecollar and the flip open cap to create a tight seal for maintainingsterility, as shown in FIG. 20. In one or more embodiments, theelongated tip may be a luer tip.

As shown in FIGS. 20A and 20B, in one or more embodiments, the cap opensin two steps, wherein a first step, the cap gets pushed up to disengagethe ring and groove features by the user pushing up with the thumb on‘Surface A’. In the second step, the cap is flipped backwards from theinitial position by pushing up with the thumb on ‘Surface A’. In one ormore embodiments, there is no need to reposition the thumb.

In one or more embodiments, Surface A has surface texture to improvefriction with the thumb of a user. In one or more embodiments, as shownin FIG. 20, finger grips 110 may be incorporated on an outside surfaceof the cap. In one or more embodiments, the finger grips 110 may befabricated from a suitable elastomer.

In one or more embodiments, the cap 40 is both easy to open by flippingit backwards (the thumb of the user moving away from the elongated tip23) and the cap is also sufficiently tight to provide minimum sterilityassurance levels. The two-step opening process enables the user todisengage the tight seal in one step and allows easy removal of the cap,as the cap is designed to prevent the need for repositioning of theuser's thumb between the two steps.

In one or more alternate embodiments, as shown in FIG. 20, the cap 40can have more than one ring-groove set features (e.g. two consecutiverings). As shown in FIG. 20, Feature B is an element that keeps the capattached to the barrel after opening. As shown in FIG. 20, a groove 42is disposed on the inside of the cap that provides a seal when closedand engaged with the seal ring 44 on the outer surface of the barrelcollar.

In one or more embodiments, as shown in FIG. 21, a skirt 150 may extendin a perpendicular direction from the top surface of the cap 40 and isdimensioned for sealing engagement with the collar.

The syringe, cap and collar may be fabricated from suitable medicalgrade materials including polymers or metals. Preferably the caps areinjection-molded using a thermoplastic and/or thermoplastic elastomer(TPE).

In one or more embodiments, the shape of the collar 30 can vary. Collar30 may have shapes including, but not limited to, circular, oval, aconvex inner surface (for example a paraboloid), concave inner surface,with a straight profile (i.e., semi conical shape), or have the shape ofa trapezoidal prism. The length of this extension from the main body ofsyringe and the degree of openness/straightness of the profile (how widethe collar is at the end farthest from the syringe barrel) can vary.

In one or more embodiments, the collar 30 surrounds an elongate tip 23adapted for connection to the hub of the vascular access devices. In oneor more embodiments, the elongate tip is a Luer tip.

Cap 40 may comprises an outward protrusion 100 that extends from thebody of the cap 40 and corresponds with the opening of the distal end ofthe elongate tip 26.

The cross-sectional shape of the cap 40 can be any suitable shapeincluding, but not limited to, circular, oval, triangular, square,pentagonal, hexagonal, heptagonal, octagonal, symmetric or non-symmetricpolygonal. The shape of the cap 40 can provide a comfortable feel forthe user and enhanced gripping ability to allow the user to easily openthe cap from the locking element 70 and corresponding mating lockingprojection 71.

The syringe assembly 10 may be filled with flush solution using knownmethods. Additionally, the syringe assembly 10 may be providedpre-filled from the manufacturer or supplier. The flush solution may beany solution intended for flushing or maintaining performance of VAD's.It is preferred that the flush solution be selected from the groupconsisting of saline flush solution and heparin lock flush solution.These solutions are known in the art and are readily available. Anexample of a saline flush solution includes, but is not limited to, 0.9%sodium chloride USP for injection. An example of a heparin lock flushsolution includes but is not limited to 0.9% sodium chloride with 100USP units of heparin sodium per mL or 10 USP units of heparin sodium permL.

Once the connection of the syringe assembly 10 to the VAD is completed,fluid communication from the barrel 20 of the syringe to the vascularaccess device can occur. Fluid is drawn from the barrel 20 through theintegral passageway 27 into the IV or catheter. Because of the presenceof the collar 30, fluid communication through a vascular access deviceand into a patient is conducted under aseptic conditions without anyadditional swabbing steps and diligence on the part of the clinician.

In one or more embodiments, the collar 30 can be integrally formed onthe distal wall 25 of the syringe barrel 20 for fluid communication tothe vascular access device.

The barrel may also include a tip 23 which extends distally from thebarrel. The tip can have an outer diameter that is different from or thesame as the outer diameter of the rest of the barrel. For example, asshown in the Figures, the outer diameter of the tip has a smaller outerdiameter than the barrel portion that is proximal of the tip. The tip ofthe barrel may include a luer slip connection or a locking luer typecollar concentrically surrounding the tip or within the tip.

As shown in FIG. 21, an elongated plunger rod 120 may include a distalportion and a proximal portion, the plunger rod further comprising adistal end including a stopper 130 slidably positioned in fluid-tightengagement with the inside surface of the barrel for drawing fluid intoand driving fluid out of the chamber by movement of the stopper relativeto the barrel, the elongated plunger rod extending outwardly from theopen proximal end 28 of the barrel 20, the stopper having a distalsurface.

An elongate plunger rod may be disposed within the barrel 20. Theplunger rod 120 includes an elongate body portion with a proximal endand a distal end.

The elongate body portion of the plunger rod has an axial lengthextending from the proximal end to the distal end. The body portion mayinclude a single beam or features, which may have cylindrical or othershapes. The body portion may be formed by two perpendicularlyintersecting beams.

The plunger rod may also include a thumb press 140 at the proximal endof the elongate body portion. The shape of the thumbpress can varydepending on the desired usage of the flush syringe assembly. The shapeof the thumb press may be round, square, rectangular, triangular, oval,pentagonal, hexagonal and cruciform.

A stopper 130 can be connected to the distal end of the plunger rod. Theshape and size of the stopper can be any suitable shape or sizedepending on, for example, the shape and size of the barrel and plungerrod. The plunger rod is slidably positioned in the barrel so that thestopper is in fluid-tight contact with the inside surface of the barreland so that distal movement of the plunger rod relative to the barrelcauses the stopper to push the fluid out of the barrel. In someembodiments, the stopper is slidably positioned in fluid-tight contactwith the inside surface of the barrel for driving fluid out of thechamber by movement of the stopper relative to the barrel. The stoppercan be connected to the distal end of the elongate plunger rod by anysuitable means. In some embodiments, the stopper is connected by amechanical connection such as interaction of complementary screw threadsand press-fit connections. The stopper may be slidably positioned influid-tight engagement with the inside surface of the barrel for drawingfluid into and driving fluid out of the chamber.

The stopper may be made of any material suitable for providing a sealwith the inside surface of the barrel. For example, the stopper may bemade of thermoplastic elastomers, natural rubber, synthetic rubber orthermoplastic materials and combinations thereof. The stopper may beintegrally formed or composed of separate components of the same ordifferent materials joined together. The plunger rod may be made ofmaterial which is more rigid than the stopper such as polypropylene,polyethylene and the like. Materials should be chosen to be compatiblewith the procedure being used.

FIG. 21. illustrates a perspective view of a flush syringe with a collarand a cap in a closed position accordance with one or more embodimentsof the present disclosure. As shown in FIG. 21, also provided aresyringe assemblies that include a plunger rod and a syringe barrelhaving an open proximal end and a distal tip, the distal syringe tipsurrounded by a collar to facilitate alignment of the syringe with acatheter hub or needle-free connector, as well as, reducingcontamination of the syringe by preventing contact of the syringe tipwith the surrounding non-sterile environment.

FIG. 22 illustrates a perspective view of a flush syringe with a collarand a cap in an open position accordance with one or more embodiments ofthe present disclosure.

FIG. 23 illustrates a perspective view of a flush syringe with a collarand a cap in an open position attached to a vascular access device 200in accordance with one or more embodiments of the present disclosure.

FIG. 24 illustrates a perspective view of a flush syringe with a collarand a cap in use in accordance with one or more embodiments of thepresent disclosure.

Although the disclosure herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent disclosure. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present disclosure as disclosed.

What is claimed is:
 1. A flush syringe assembly comprising: a barrelincluding a side wall having an inside surface defining a chamber forretaining a fluid, an open proximal end, a distal end including a distalwall with an elongate tip extending distally therefrom having apassageway therethrough in fluid communication with said chamber; acollar mounted on the distal wall of the barrel and surrounding theelongate tip, the collar including at least one side wall having aninside surface defining a compartment, an open distal end, a proximalend adjacent the distal wall of the barrel; a cap attached to the collarvia a hinge; a gasket is disposed between the collar and the cap; and anelongated plunger rod disposed within the barrel, the elongated plungerrod comprising a distal end and a proximal end, the distal end includinga stopper slidably positioned in fluid-tight engagement with the insidesurface of the barrel for drawing fluid into and driving fluid out ofthe chamber by movement of the stopper relative to the barrel, theelongated plunger rod extending outwardly from the open proximal end ofthe barrel.
 2. The flush syringe assembly of claim 1, wherein thecompartment of the collar surrounds the elongated tip.
 3. The flushsyringe assembly of claim 1, wherein the hinge is a living hinge.
 4. Theflush syringe assembly of claim 1, wherein the hinge is a butterflyshape with a central hinge section and two lateral wings.
 5. The flushsyringe assembly of claim 1, wherein the hinge is spring loaded.
 6. Theflush syringe assembly of claim 5, wherein the hinge opens between afully closed position to a fully open position of at least 120 degrees.7. The flush syringe assembly of claim 1, wherein the cap includes anoutwardly extending protrusion that interacts with the elongate tip. 8.The flush syringe assembly of claim 7, wherein the protrusion isbutton-shaped.
 9. The flush syringe assembly of claim 7, wherein theprotrusion is pin-shaped.
 10. The flush syringe assembly of claim 7,wherein the protrusion is umbrella-shaped.
 11. The flush syringeassembly of claim 1, wherein the cap includes a slanted surface.
 12. Theflush syringe assembly of claim 11, wherein the slanted surface includesone or more ribs.
 13. The flush syringe assembly of claim 12, whereinthe one or more ribs are made of an elastomeric material.
 14. The flushsyringe assembly of claim 1 further comprising a ring around the collarwith a locking element that engages with a corresponding mating lockingprojection on the cap.
 15. The flush syringe assembly of claim 14,wherein the ring is turned to disengage the locking element from matinglocking projection on the cap.
 16. The flush syringe assembly of claim14, wherein the ring includes one or more thumb supports.
 17. The flushsyringe assembly of claim 14, wherein the locking element is shaped in aform of an arm.